A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel

Acne Vulgaris Clinical Trial

Official title:

A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of CT Gel in Subjects With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689117
• Other study ID #: 114681
• Secondary ID: W0265-03
• Status: Completed
• Phase: Phase 3
• First received: May 24, 2008
• Last updated: May 25, 2017
• Start date: April 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.

Description:

CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1649
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Male or female 12 years of age or older in good general health

• Investigator's Static Global Assessment (ISGA) score of 2 or greater at Baseline

Exclusion Criteria:

• Any nodulo-cystic lesions at Baseline

• Pregnancy or breast feeding

• History or presence of regional enteritis or inflammatory bowel disease or similar symptoms.

• Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less prior to study start.

• Use of topical anti-acne medications within the past 2 weeks.

• Use of topical or systemic antibiotics on the face within the past 2 weeks.

• Use of topical or systemic corticosteroids within the past 2 weeks.

• Use of systemic retinoids within the past 3 months.

• Use of astringents, toners and skin cleansers for less than 2 weeks prior to the start of the study.

• Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or a- or ß-hydroxy acids.

• Concomitant use of mega-doses of certain vitamins, such as vitamin D (>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.

• Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.

• Concomitant use of tanning booths or sunbathing.

• Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, retinoids or excipients of the study product

• A significant medical history of or are currently immunocompromised

• Current drug or alcohol abuse. (Drug screening not required.)

• Use of any investigational therapy within 4 weeks of enrollment.

• Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• CT Gel
Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
• Clindamycin Gel (clindamycin )
Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
• Tretinoin Gel (tretinoin)
Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
• Vehicle Gel
Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks

Locations

Country	Name	City	State
Belize	Dermatology And Skin Centre	Belize City
Belize	Dr. Moguel's Clinic	Belize City
Canada	Innovaderm Research, Inc.	Montreal	Quebec
Canada	K. Papp Clinical Research, Inc.	Waterloo	Ontario
Canada	Windsor Clinical Research Center, Inc.	Windsor	Ontario
United States	Academic Dermatology Research	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	DermResearch, Inc.	Austin	Texas
United States	Radiant Research	Birmingham	Alabama
United States	Massachusettes General Hospital - Clinical Unit for Research Trials in Skin	Boston	Massachusetts
United States	Dermatology Research Associates, Inc.	Cincinnati	Ohio
United States	J & S Studies, Inc.	College Station	Texas
United States	The Hair and Skin Research Treatment Center	Dallas	Texas
United States	Henry Ford Medical Center	Detroit	Michigan
United States	Center for Dermatology, Cosmetic and Laser Surgery	Fremont	California
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Dermatology Associates of Knoxville, P.C.	Knoxville	Tennessee
United States	Longmont Medical Research Network	Longmont	Colorado
United States	Dermatology Specialists	Louisville	Kentucky
United States	FXM Research Corporation	Miami	Florida
United States	Advanced Healthcare	Milwaukee	Wisconsin
United States	FXM Research - Miramar	Miramar	Florida
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Tennessee Clinical Research	Nashville	Tennessee
United States	Skin Specialists, P.C.	Omaha	Nebraska
United States	Advanced Dermatolgy & Cosemtic Surgery	Ormond Beach	Florida
United States	Dermatology Research Center, Inc.	Salt Lake City	Utah
United States	University Clinical Trials	San Diego	California
United States	Premier Clincial Research	Spokane	Washington
United States	Yardley Dermatology Associates	Yardley	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Stiefel, a GSK Company	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belize,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)	Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.	Baseline, Week 12
Primary	The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12	The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.	Baseline, Week 12
Secondary	Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12	Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.	Baseline, Week 12
Secondary	The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12	The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts.	Week 12
Secondary	The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12	The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion.	Week 12